An allograft includes bone, tendon, skin, or other types of tissue that is transplanted from one person to another. Allografts are used in a variety of medical treatments, such as knee replacements, bone grafts, spinal fusions, eye surgery, and skin grafts for the severely burned. Allografts come from voluntarily donated human tissue obtained from cadaveric donor-derived, living-related, or living-unrelated donors and can help patients regain mobility, restore function, enjoy a better quality of life, and even save lives in the case of cardiovascular tissue or skin.
When a ligament or tendon becomes detached from the bone, surgery is usually required to re-secure the ligament or tendon. Often, a substitute allograft ligament or tendon (hereinafter an “allograft construct” or “allograft tendon construct”) is attached to the bone to facilitate regrowth and permanent attachment. The reattachment procedure involves drilling a bone tunnel between two bones such as, for example, the tibia and the femur, and securing the allograft construct within the tunnel.
Traditionally, surgeons have been responsible for tendon graft preparation, individually preparing an appropriately cross-sectioned, whip-stitched tendon for each patient and/or circumstance in the operating theatre. Recently, pre-sutured allograft tendon constructs have become available from third-party providers, such as, for example, allograft processing centers, thereby allowing surgeons to order high quality, consistent, strong, and sterile pre-sutured tendon constructs, either individually or as part of a larger “kit” carrying a variety of pre-sutured construct sizes.
Pre-sutured tendon constructs are oftentimes pre-tensioned prior to fixation between the anchoring bones of the recipient to evaluate the integrity of the constructs and to ensure that each pre-sutured tendon construct is prepared based on a “book” value of tension force, rather than simply by “feel,” which is generally the case with surgeons who prepare tendon constructs in the operating theatre.
Existing tooling setups for pre-suturing and pre-tensioning or testing tendon constructs are generally oversized, cumbersome, non-customizable and configured for only a specific suturing method and/or tissue or construct type, and are further ill-suited for use in a clean room environment and for sterilization in an autoclave or other sterilizing processor.